- Bristol Myers Squibb (New Brunswick, NJ)
- …allocation of DS and API materials for non- clinical use. + The CMC Project Manager may co-lead and/or contribute to Product Development portfolio level ... ( CMC ) to enable R&D Development Team objectives/deliverables. **Position:** Senior Manager , CMC Project Operations **Location:** New Brunswick NJ The… more
- BeiGene (San Mateo, CA)
- …company goals. This individual will be responsible for development of strategies, planning , drafting, and managing CMC -related regulatory submissions to meet ... complaints arise during product lifecycle for assigned projects. + Provide regulatory CMC review of clinical protocols and investigator brochures, etc. for… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …some complexity. This position makes decisions with consultation. **Responsibilities:** + ** Planning for Development :** Manages multiple CMC development ... CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub...technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing… more
- Merck (Boston, MA)
- …Section of the GCS Planning organization. Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates strategic ... clinical supply chain across the full company's Research Laboratories portfolio of clinical trials. GCS is accountable for the planning , sourcing, labelling,… more
- BeiGene (San Mateo, CA)
- **General Description:** The Manager of Clinical Supply Chain manages drug supply activities related to planning , label development, label & pack, and ... and provide a high service level to internal stakeholders (eg Clinical Operations, Regulatory, Quality, CMC ). + Work with Clinical Operations to understand … more
- Merck (West Point, PA)
- …Development Sciences and Clinical Supply (DSCS) organization, the Digital Program Manager will advance the purpose and aspiration of our Company's DSCS Digital ... robustness across organizational deliverables. In this role, the DSCS Digital Program Manager will provide strategic and tactical direction and partner with the DSCS… more
- Novo Nordisk (Boulder, CO)
- …and dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Manager of Drug Product Manufacturing ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Option Care Health (Tallahassee, FL)
- …aspects of patient registration responsibilities within the Customer Management Center ( CMC ). The Manager , Patient Registration manages the overall performance ... and chronic conditions in all 50 states. Through our clinical leadership, expertise and national scale, Option Care Health...+ Directly oversees the patient registration activities with the CMC to ensure all performance expectations for time to… more
- ERP International (Lemoore, CA)
- …* Provide nursing expertise about the CM process, including assessment, planning , implementation, coordination, and monitoring. Identify opportunities for CM and ... such as those used for patient identification and patient assessment, clinical practice guidelines, algorithms, CM software, and databases for community resources.… more
- Johns Hopkins University (Baltimore, MD)
- …for study participants. + Meet with Principal Investigator to discuss strategic planning for future research projects. _Provide clinical research coordination ... review committee (CDERC), and independent radiology reads. + Coordinate the SMILE-TB Clinical Monitoring Committee ( CMC ) including monthly meetings on study… more
- ERP International (Camp Pendleton, CA)
- **Overview** ERP International, LLC is seeking a **Registered Nurse - Case Manager ** for a full-time position supporting **Branch Health Clinic Port Hueneme, CA** in ... * Provide nursing expertise about the CM process, including assessment, planning , implementation, coordination, and monitoring. Identify opportunities for CM and… more
- Fujifilm (Holly Springs, NC)
- …North Carolina, United States. **External US** **About This Role** The Senior Program Manager is accountable for the planning and delivery of programs from ... vision / mission (strategy and compliance). The Sr. Program Manager handles an average load of 1-3 programs and...**What You'll Do** **Execution / Delivery:** + Leads the planning and execution of programs in alignment with FDB… more
- ERP International (Twentynine Palms, CA)
- …Case Manager (RN-NCM) o National Academy of Certified Care Managers: Care Manager Certified ( CMC ) Life Support Certifications:** AHA or ARC BLS Security:** ... * Provide nursing expertise about the CM process, including assessment, planning , implementation, coordination, and monitoring. Identify opportunities for CM and… more
- Fujifilm (Holly Springs, NC)
- …US** **About This Role** The Associate Program Director (APD) is accountable for the planning & delivery of programs from the point of contract signature (Scope of ... a set of programs for one Drug Substance Manufacturing suite + Leads the planning and execution of programs in alignment with FDB Program Management business case… more
- Takeda Pharmaceuticals (Boston, MA)
- …of development with significant experience within related functions (eg Marketing, Clinical Operations, Regulatory, Manufacturing, CMC , Clinical Science) ... efficiently executable plan working closely with a senior GPM; predicting and planning solutions to achieve program goals and objectives; driving clarity and… more
- CVS Health (Austin, TX)
- …and care coordination activities across the continuum of care (assessing, planning , implementing, coordinating, monitoring, and evaluating). The CMC utilizes ... service needs that may impact member outcomes and care planning with appropriate referral to clinical case... hand offs during transitions of care. Report to: Manager , Clinical Health Services, Care Management **Required… more
- Novo Nordisk (Watertown, MA)
- … Manager , Warehouse & Logistics. Essential Functions + Support CMC development sites with logistics leadership, technical information to enable execution ... NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating...entries into US from Broker for filling information for CMC Development and Scaling + Maintain permits, execute permit… more
- Amicus Therapeutics (Princeton, NJ)
- …workstreams by partnering with key stakeholders including but not restricted to CMC , Clinical , Clinical Operations, Regulatory, Patient Advocacy, IP/Legal, ... Management represents Program Management in the Brand Leadership Team. A Manager , Program Management provides support to the Executive Director, Program Management… more
- Covenant Health Inc. (Crossville, TN)
- …seriously ill patients, advanced medical and surgical care is provided at CMC including telemetry monitored beds and an intensive care unit. Additionally, Cumberland ... for additional job responsibilities which may include: program development, clinical coordination of students, scheduling of supportive staff and coordinating… more
- System One (Florham Park, NJ)
- …+ Proven experience in preparing and submitting regulatory documents, including nonclinical, clinical , CMC , DMF, and labeling/SPL., in eCTD format. + Thorough ... different application types (eg, IND, NDA/BLA, MAA, CTA DMF). Participate in project- planning meetings to provide input on submission timelines in collaboration with… more
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